Voyager Therapeutics, Inc. (Nasdaq: VYGR), a clinical-stage gene therapy company developing life-changing treatments for severe neurological diseases, today announced the U.S. Food and Drug Administration (FDA) has removed its clinical hold on the company’s Investigational New Drug (IND) application for VY-HTT01, a gene therapy candidate for the treatment of Huntington’s disease (HD), and confirmed that the company may proceed with its planned Phase 1/2 clinical trial. The decision was made following a comprehensive review of the Chemistry, Manufacturing and Controls information previously submitted to the FDA. Voyager plans to initiate VYTAL, a Phase 1/2 clinical trial of VY-HTT01, this year.
Monday, April 26, 2021
Death, Disability Among Side Effects of Chinese COVID-19 Vaccines: Leaked Documents
Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China. Tellingly, one of the documents listing the reactions came with an admonishment to not share that news with the public, according to a report in The Epoch Times.
The revelation came just days before the World Health Organization (WHO)’s planned April 26 review of the Sinovac COVID-19 vaccine for emergency use.
One document noted that “suspected group vaccination adverse reactions (include) death, and severe disability of the recipients.” That appeared in the “Notice of Further Strengthening the Safety Management of COVID-19 Vaccination,” issued April 6 by the Leadership Team for Epidemic Response within the Hebei provincial government.
That document was marked, “extra urgent, and non-disclosure to the public.” It required agencies to “strengthen the monitoring and handling of the adverse reactions that would have a major negative impact on society,” The Epoch Times reported, showing a Chinese-language photo of the report.
A second report documented rashes, fever, nausea, diarrhea, chest tightness and shortness of breath resulting from Chinese COVID-19 vaccinations. It was entitled “Statistical Table of Adverse Reactions of COVID-19 Vaccines,” and listed adverse events from Laishui Community Health Service Center of Laishui County at Baoding City, also in Hebei province. It was issued April 8.
A third document detailed the 47-day (and counting) quarantine of an individual who was fully vaccinated yet continued to test positive for the virus. Called the “Request for Consultation with Provincial Experts on a Resident Surnamed Sui,” the document was issued March 3 by the office of the Baoding municipal Leadership Team for Response to the Epidemic.
As it details, Sui, a resident of the Lianchi District of the city of Baoding, received two doses of a Chinese-made COVID-19 vaccine in December 2020, then traveled to Germany. Upon return, he was quarantined at a centralized quarantine site. During quarantine, Sui took five comprehensive tests, including CT, blood serum, nucleic acid and routine blood tests. IgM antibodies, which denote a recent infection, were found in the blood serum tests each time. At the time of the report, per China policy, Sui was still quarantined and waiting for a negative test.
According to The Epoch Times, Chinese experts consulting on Sui’s case suggest that the positive results for IgM may be a side effect of the vaccination. The reason, they said, is that some individuals may test positive for half a year. Others given the same vaccine may test negative. The difference depends upon their physical condition.
Given Sui’s case, other adverse events in municipal and provincial reports within China, and reports throughout the world regarding adverse events, the safety of the Sinovac and Sinopharm vaccines is concerning.
Earlier in the year, Tao Lina. M.D., a Shanghai vaccine expert, posted the physician manual for the vaccine, listing 73 adverse events associated with the Chinese vaccine. He called it the “most unsafe vaccine in the world.” He retracted his statements a few days later.
China’s COVID-19 vaccines have been distributed to at least 50 nations, and the list is growing. As they roll out, various countries are compiling their own lists of mostly minor side effects. For example, CNN Philippines reported that the most common adverse events associated with Sinovac's COVID-19 vaccine are elevated blood pressure, headache, injection site pain, dizziness and rash. Egypt reported similarly minor side effects. Pakistan likewise reported no adverse side effects.
Since the Sinovac COVID-19 vaccine rollout, the vaccine also has been plagued by disparate efficacy claims. As Reuters reported, Brazil claimed the Sinovac vaccine is 50.7% effective, just over the 50% mark required by the World Health Organization and well below the 78% efficacy rate touted when the vaccine was announced in China last January.
A real-world study from Chile announced by the Ministry of Health in a news conference April 16, boosts efficacy rates to 67% in terms of preventing symptomatic infection, 85% at preventing hospitalizations, 89% at preventing admission to the intensive care unit and 80% at preventing death. That report, however, did not specifically assess the vaccine against any of the emerging variants.
The Global Times (the English edition of People’s Daily – the official publication of the Chinese Communist Party’s Central Committee), in late April claimed an adverse event rate of 1.06% among the more than 519,000 people inoculated by December 1, 2020. That was far lower than the 13% and 19% rates reported in Phase II trials.
Gao Fu, director of China’s Center for Disease Control and Prevention, admitted the low efficacy rates of China’s vaccines in a surprising statement at China’s National Vaccine and Health Conference April 10. Consequently, he said, “It’s now under consideration whether we should use different vaccines from different technical lines for the immunization process.” A few days later, he walked back his comments, saying they were misunderstood and actually applied to vaccines globally.
So far, China has administered 216.08 million COVID-19 vaccines, according to data released by the National Health Commission April 24, 2021.
Vedanta shares jump as smelter to reopen to produce oxygen for hospitals
Shares of Indian oil-to-metals conglomerate Vedanta Ltd rose nearly 4% on Monday after Tamil Nadu state authorised the company's shuttered copper smelter to produce oxygen for medical purposes to help the country tackle its deepening coronavirus crisis.
The smelter has been closed for nearly three years due to concerns about pollution.
"It was decided in an all-party meeting that Vedanta be allowed to operate the oxygen plant for a temporary period of four months," the Tamil Nadu government said in a statement, adding that production of copper would not be permitted.
Vedanta's shares, which have nearly tripled over the last year, rose by as much as 5.1% on Monday before paring gains to close 3.8% higher at 236.65 rupees, their best performance in more than two months.
Overcrowded hospitals in Delhi and elsewhere are turning away patients after running out of supplies of medical oxygen and beds as new coronavirus infections in India hit a record peak for a fifth day on Monday.
Environmentalists and local activists, however, raised concerns that the move to allow the smelter to reopen temporarily could provide a "backdoor entry" for Vedanta. The state ordered the 400,000 tonne per annum Sterlite copper smelter to close in May 2018, a week after police killed 13 protesters seeking the plant's closure for alleged pollution.
"Under any circumstances, the polluting Sterlite Copper plant will not be allowed to open," M.K. Stalin, the main opposition leader in the state, said in a tweet.
Vedanta said it was working with experts to resolve the logistics of dispatching oxygen.
"We are committed to making the entire production capacity of 1,000 tonnes available for the purpose of producing medical grade oxygen," it said in a statement.
The company has consistently denied allegations of pollution, and has appealed to the country's Supreme Court, seeking to reopen the plant.
Vedanta, controlled by billionaire Anil Agarwal, said last month it was looking for an Indian state government partner to set up a 100 billion rupee ($1.37 billion) copper smelter.
Reviva Details Positive Phase 2 Clinical Trial Results for Acute Schizophrenia
Met endpoints for safety and efficacy in 234 patients’ clinical trial with Acute Schizophrenia or Schizoaffective Disorder
Met primary endpoint of reduction in Positive and Negative Syndrome Scale (PANSS) total score for Schizophrenia
Mitigated positive symptoms and negative symptoms
Improved social functioning and cognition.
No metabolic (weight gain, elevated blood sugar, increase in lipids), no endocrine (hypothyroidism, hyperprolactinemia) side effects and no increase in suicidal ideation compared to placebo.
LivaNova, Verily Enroll for Depression Study
UNCOVER is an opt-in research study for patients taking part in the ongoing LivaNova clinical study RECOVER or "A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® as Adjunctive Therapy Versus a No Stimulation Control in Subjects with Treatment-Resistant Depression." The UNCOVER sub-study deploys technology-enabled research tools from Verily to evaluate the real-world effectiveness of VNS Therapy as an adjunctive treatment for difficult-to-treat depression (DTD). The first UNCOVER patient was enrolled by Dr. David L. Dunner, FACPsych, Director of the Center for Anxiety and Depression in Mercer Island, Wash., and Professor Emeritus at the University of Washington in Seattle.
Participants in the UNCOVER sub-study will use two Verily-developed digital tools – a wearable, multi-sensor device (Verily Study Watch) along with an Android smartphone application (Verily Mood App). The Verily tools measure passive and active data, such as the participant’s pulse rate, activity levels and sleep quality. The Mood App also allows participants to record voice diaries to more accurately assess depressive episodes and their effect on daily living.
https://finance.yahoo.com/news/livanova-verily-announce-first-patient-130000968.html
Scopus BioPharma Submits IND for Cancer RNA Therapy
Drug Candidate is Distinctive RNA Therapy and Immunotherapy Developed at City of Hope for Treatment of Multiple Cancers
IND Filing a Key Milestone for Planned Phase 1 Clinical Trial to be Initiated at City of Hope
Scopus BioPharma Inc. (Nasdaq: "SCPS") today announced the submission of an investigational new drug application ("IND") to the United States Food and Drug Administration ("FDA") for its immuno-oncology RNA therapy for the treatment of multiple cancers. The IND filing is a key milestone for the planned Phase 1 clinical trial for B-cell non-Hodgkin lymphoma to be initiated at City of Hope.
https://finance.yahoo.com/news/scopus-biopharma-announces-ind-submission-132500201.html
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